NCT00322387 · OUTCOME
Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- transplants
- Interval / dispersion
- Not reported
- Time frame
- 2 months
What was measured
Participants were monitored for polymorphonuclear leukocyte (PMN) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment.
Analysis population: Intent to treat population. Six participants with MM had 2 transplants.
Groups in this outcome
Non-Hodgkin's Lymphoma (NHL): Plerixafor PM
Participants with NHL who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
Non-Hodgkin's Lymphoma (NHL): Plerixafor AM
Participants with NHL who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo
Participants with NHL who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery. Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached \>= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms.
Multiple Myeloma (MM): Plerixafor PM
Participants with MM who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
Multiple Myeloma (MM): Plerixafor AM
Participants with MM who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM
Participants with MM who followed the Low CD34+ Count/Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. If participants had a CD34+ count of \>=10 cells/µL but \<20 cells/µL on 2 consecutive days, plerixafor (240 µg/kg) was given in the evening. G-CSF was administered and apheresis performed in the morning. Plerixafor (240 µg/kg) administered in the evening followed by G-CSF and apheresis 10 to 11 hours later was repeated for up to 4 consecutive days.
Multiple Myeloma (MM): Plerixafor After Chemo
Participants with MM who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery. Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached \>= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms.
| Group | Source count |
|---|---|
| Non-Hodgkin's Lymphoma (NHL): Plerixafor PM | 7 |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor AM | 6 |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo | 1 |
| Multiple Myeloma (MM): Plerixafor PM | 12 |
| Multiple Myeloma (MM): Plerixafor AM | 9 |
| Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM | 1 |
| Multiple Myeloma (MM): Plerixafor After Chemo | 4 |
| Group | Source count |
|---|---|
| Non-Hodgkin's Lymphoma (NHL): Plerixafor PM | 7 |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor AM | 6 |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo | 1 |
| Multiple Myeloma (MM): Plerixafor PM | 14 |
| Multiple Myeloma (MM): Plerixafor AM | 12 |
| Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM | 2 |
| Multiple Myeloma (MM): Plerixafor After Chemo | 4 |
Reported measurements
≤ Day 12
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Non-Hodgkin's Lymphoma (NHL): Plerixafor PM | 6 | Not reported | Not reported | Not reported | Not reported |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor AM | 4 | Not reported | Not reported | Not reported | Not reported |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo | 0 | Not reported | Not reported | Not reported | Not reported |
| Multiple Myeloma (MM): Plerixafor PM | 14 | Not reported | Not reported | Not reported | Not reported |
| Multiple Myeloma (MM): Plerixafor AM | 9 | Not reported | Not reported | Not reported | Not reported |
| Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM | 1 | Not reported | Not reported | Not reported | Not reported |
| Multiple Myeloma (MM): Plerixafor After Chemo | 0 | Not reported | Not reported | Not reported | Not reported |
Day 13 to Day 21
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Non-Hodgkin's Lymphoma (NHL): Plerixafor PM | 1 | Not reported | Not reported | Not reported | Not reported |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor AM | 2 | Not reported | Not reported | Not reported | Not reported |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo | 1 | Not reported | Not reported | Not reported | Not reported |
| Multiple Myeloma (MM): Plerixafor PM | 0 | Not reported | Not reported | Not reported | Not reported |
| Multiple Myeloma (MM): Plerixafor AM | 3 | Not reported | Not reported | Not reported | Not reported |
| Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM | 1 | Not reported | Not reported | Not reported | Not reported |
| Multiple Myeloma (MM): Plerixafor After Chemo | 4 | Not reported | Not reported | Not reported | Not reported |
≥ Day 22
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Non-Hodgkin's Lymphoma (NHL): Plerixafor PM | 0 | Not reported | Not reported | Not reported | Not reported |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor AM | 0 | Not reported | Not reported | Not reported | Not reported |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo | 0 | Not reported | Not reported | Not reported | Not reported |
| Multiple Myeloma (MM): Plerixafor PM | 0 | Not reported | Not reported | Not reported | Not reported |
| Multiple Myeloma (MM): Plerixafor AM | 0 | Not reported | Not reported | Not reported | Not reported |
| Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM | 0 | Not reported | Not reported | Not reported | Not reported |
| Multiple Myeloma (MM): Plerixafor After Chemo | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 14
- group Id
- OG004
- value
- 9
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- title
- ≤ Day 12
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 4
- title
- Day 13 to Day 21
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- title
- ≥ Day 22
- denom Units Selected
- Participants
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 12
- group Id
- OG004
- value
- 9
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 4
- units
- Participants
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 14
- group Id
- OG004
- value
- 12
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 4
- units
- transplants
- description
- Participants were monitored for polymorphonuclear leukocyte (PMN) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment.
- groups
- description
- Participants with NHL who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
- id
- OG000
- title
- Non-Hodgkin's Lymphoma (NHL): Plerixafor PM
- description
- Participants with NHL who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
- id
- OG001
- title
- Non-Hodgkin's Lymphoma (NHL): Plerixafor AM
- description
- Participants with NHL who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery. Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached \>= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms.
- id
- OG002
- title
- Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo
- description
- Participants with MM who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
- id
- OG003
- title
- Multiple Myeloma (MM): Plerixafor PM
- description
- Participants with MM who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
- id
- OG004
- title
- Multiple Myeloma (MM): Plerixafor AM
- description
- Participants with MM who followed the Low CD34+ Count/Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. If participants had a CD34+ count of \>=10 cells/µL but \<20 cells/µL on 2 consecutive days, plerixafor (240 µg/kg) was given in the evening. G-CSF was administered and apheresis performed in the morning. Plerixafor (240 µg/kg) administered in the evening followed by G-CSF and apheresis 10 to 11 hours later was repeated for up to 4 consecutive days.
- id
- OG005
- title
- Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM
- description
- Participants with MM who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery. Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached \>= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms.
- id
- OG006
- title
- Multiple Myeloma (MM): Plerixafor After Chemo
- param Type
- NUMBER
- population Description
- Intent to treat population. Six participants with MM had 2 transplants.
- reporting Status
- POSTED
- time Frame
- 2 months
- title
- Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant
- type
- SECONDARY
- type Units Analyzed
- transplants
- unit Of Measure
- transplants
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